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Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neck Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for ALL participants:

  • Age 21-65 years
  • Independently ambulatory
  • Able to speak and read English
  • Able to understand study procedures and to comply with them for the entire length of the study.

Below is an additional list of inclusion criteria for NECK PAIN participants:

  • Willing to be randomized to either immediate or delayed treatment group.
  • Musculoskeletal pain - primarily in the cervical region lasting longer than 3 months
  • Pain rating greater than or equal to 3 out of 10 as indicated on the Numeric Rating Scale for Pain
  • Neck Disability greater than or equal to 30% as indicated on the Neck Disability Index

Exclusion Criteria:

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded.

Below is a list of exclusion criteria for ALL participants:

  • Inability or unwillingness of individual to give written informed consent.
  • Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment
  • Workers' compensation benefits in the past 3 months or ongoing medical legal issues
  • Possibly pregnant
  • Extreme obesity (BMI>36)
  • Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.)

History of:

  • Spinal surgery
  • Spinal fracture
  • Spinal infection (e.g., osteomyelitis)
  • Cancer

Unresolved symptoms from:

  • Head trauma
  • Inner ear infection with associated balance and coordination problems
  • Orthostatic hypotension
  • Uncontrolled hypertension
  • Vestibular disorder (e.g. vertigo)

Current diagnosis of:

  • Significant spinal deformity (e.g., scoliosis > 20 degrees, torticollis)
  • Ankylosing spondylitis
  • Spondylolisthesis grades III or IV
  • Rheumatoid arthritis
  • Osteoporosis
  • Angina or congestive heart failure symptoms
  • Active bleeding or infection in the back
  • Blindness
  • Seizures
  • Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia)

Conditions recognized by a physician any time during the study:

  • Significant or worsening signs of neurologic deficit
  • Symptoms are not consistent with mechanical findings
  • Other conditions impeding protocol implementation

Below is an additional exclusion criterion for healthy control participants:

• Based on the minimal clinically important difference of 2 points (Childs et al., 2005), "healthy controls" with 2 points or greater pain on NRS will not be eligible to participate.

Sites / Locations

  • MSU Osteopathic Manual Medicine
  • MSU Musculoskeletal Rehabilitation
  • Michigan State University Center for Orthopedic Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Immediate treatment

Delayed treatment

Healthy control (no neck pain)

Arm Description

This arm receives osteopathic manipulative treatment shortly after enrollment

This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment

In this arm, healthy controls are tested at baseline.

Outcomes

Primary Outcome Measures

Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy
Participants will be seated in an upright position with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The angular position of the head will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their head. Accuracy will be determined by taking the difference between the target position signal and the actual head position (measured in degrees with string potentiometers).
Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their head. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their head. Accuracy will be determined by taking the difference between target force signal and the actual head force (measured in Newtons with the load cell).
Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy
Participants will be sitting upright in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the cervical spine in the sagittal plane while the participant is asked to maintain (stabilize) their head position in the upright posture. Accuracy will be determined by measuring the amount of head displacement (measured in degrees with string potentiometers) during the perturbation trial.
Change from baseline to week 4 in neck force and muscle activation directionality
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.
Change from week 4 to 8 in neck force and muscle activation directionality
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.

Secondary Outcome Measures

Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Change in concomitant medication
Assesses weekly changes in the use of medication for treating neck pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.
Change in neck disability
Assesses weekly changes in functional activities related to neck disability with the Neck Disability Index questionnaire.
Change in fear avoidance behavior
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.

Full Information

First Posted
September 19, 2014
Last Updated
January 2, 2019
Sponsor
Michigan State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02261259
Brief Title
Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System
Official Title
Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
November 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of head-neck motor control. In order to accomplish this goal, the investigators aim to quantify changes in head-neck motor control before and after osteopathic manipulative treatment. The investigators hypothesize that head-neck motor control will improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators will compare position and force head-neck motor control between healthy controls and neck pain patients. The investigators hypothesize that baseline tests of position and force head-neck motor control will be better in healthy individuals than neck pain patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate treatment
Arm Type
Experimental
Arm Description
This arm receives osteopathic manipulative treatment shortly after enrollment
Arm Title
Delayed treatment
Arm Type
Experimental
Arm Description
This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment
Arm Title
Healthy control (no neck pain)
Arm Type
No Intervention
Arm Description
In this arm, healthy controls are tested at baseline.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
Up to 4 sessions of osteopathic manipulative treatment (once per week)
Primary Outcome Measure Information:
Title
Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy
Description
Participants will be seated in an upright position with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The angular position of the head will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their head. Accuracy will be determined by taking the difference between the target position signal and the actual head position (measured in degrees with string potentiometers).
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy
Description
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their head. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their head. Accuracy will be determined by taking the difference between target force signal and the actual head force (measured in Newtons with the load cell).
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy
Description
Participants will be sitting upright in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the cervical spine in the sagittal plane while the participant is asked to maintain (stabilize) their head position in the upright posture. Accuracy will be determined by measuring the amount of head displacement (measured in degrees with string potentiometers) during the perturbation trial.
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 in neck force and muscle activation directionality
Description
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.
Time Frame
Change from baseline to week 4
Title
Change from week 4 to 8 in neck force and muscle activation directionality
Description
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.
Time Frame
Change from week 4 to 8
Secondary Outcome Measure Information:
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Description
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Title
Change in concomitant medication
Description
Assesses weekly changes in the use of medication for treating neck pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Title
Change in neck disability
Description
Assesses weekly changes in functional activities related to neck disability with the Neck Disability Index questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Title
Change in fear avoidance behavior
Description
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for ALL participants: Age 21-65 years Independently ambulatory Able to speak and read English Able to understand study procedures and to comply with them for the entire length of the study. Below is an additional list of inclusion criteria for NECK PAIN participants: Willing to be randomized to either immediate or delayed treatment group. Musculoskeletal pain - primarily in the cervical region lasting longer than 3 months Pain rating greater than or equal to 3 out of 10 as indicated on the Numeric Rating Scale for Pain Neck Disability greater than or equal to 30% as indicated on the Neck Disability Index Exclusion Criteria: All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded. Below is a list of exclusion criteria for ALL participants: Inability or unwillingness of individual to give written informed consent. Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment Workers' compensation benefits in the past 3 months or ongoing medical legal issues Possibly pregnant Extreme obesity (BMI>36) Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.) History of: Spinal surgery Spinal fracture Spinal infection (e.g., osteomyelitis) Cancer Unresolved symptoms from: Head trauma Inner ear infection with associated balance and coordination problems Orthostatic hypotension Uncontrolled hypertension Vestibular disorder (e.g. vertigo) Current diagnosis of: Significant spinal deformity (e.g., scoliosis > 20 degrees, torticollis) Ankylosing spondylitis Spondylolisthesis grades III or IV Rheumatoid arthritis Osteoporosis Angina or congestive heart failure symptoms Active bleeding or infection in the back Blindness Seizures Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia) Conditions recognized by a physician any time during the study: Significant or worsening signs of neurologic deficit Symptoms are not consistent with mechanical findings Other conditions impeding protocol implementation Below is an additional exclusion criterion for healthy control participants: • Based on the minimal clinically important difference of 2 points (Childs et al., 2005), "healthy controls" with 2 points or greater pain on NRS will not be eligible to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Cholewicki, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norman P Reeves, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MSU Osteopathic Manual Medicine
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
MSU Musculoskeletal Rehabilitation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48891
Country
United States
Facility Name
Michigan State University Center for Orthopedic Research
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24262851
Citation
Reeves NP, Popovich JM Jr, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Reliability of assessing trunk motor control using position and force tracking and stabilization tasks. J Biomech. 2014 Jan 3;47(1):44-9. doi: 10.1016/j.jbiomech.2013.10.018. Epub 2013 Oct 22.
Results Reference
background
Links:
URL
http://orthopedicresearch.msu.edu/
Description
Website for Michigan State University Center for Orthopedic Research
URL
http://nccam.nih.gov/
Description
Website for the National Center for Complementary and Alternative Medicine (Sponsor)

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Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System

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